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round/Objective: The objective of this clinical trial is to evaluate the clinical efficacy of a resin infiltrant (Icon®, DMG) compared to an ionomer-based fluoride varnish (Clinpro XT®, 3M) in preventing post-eruptive enamel breakdown (PEB) in permanent molars with mild Molar Incisor Hypomineralization (MIH).
Research Question: Can resin infiltration effectively prevent post-eruptive enamel breakdown in permanent molars with mild MIH compared to an ionomer-based fluoride varnish? Methodology: The researchers will compare the resin infiltrant Icon® (DMG) with Clinpro XT® Varnish (3M) to prevent post-eruptive enamel breakdown in permanent molars with mild MIH.
Participants:
Children aged 6 to 13 years presenting at least two permanent molars affected by mild MIH, with no prior structural loss or previous dental treatment.
Requirement to attend follow-up evaluations at 15 days, 1 month, 3 months, and 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resin Infiltrant (Icon®) | Experimental | Participants will receive resin infiltration (Icon®, DMG) on one permanent molar affected by mild MIH. The side (left or right) will be determined by random allocation |
|
| Ionomer-Based Fluoride Varnish (Clinpro XT®) | Active Comparator | Participants will receive ionomer-based fluoride varnish (Clinpro XT®, 3M) on the contralateral permanent molar affected by mild MIH |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resin Infiltrant (Icon®, DMG) | Other | Application of a low-viscosity light-cured resin (Icon®) after surface pretreatment with 15% hydrochloric acid gel (Icon-Etch). The resin is applied to the affected permanent molar to seal the porous enamel and prevent post-eruptive breakdown. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-eruptive breakdown (PEB) | The primary outcome is the occurrence of Post-Eruptive Breakdown (PEB), defined as the loss of enamel structural integrity resulting in cavitation or a clinical 'step-off' appearance within the hypomineralized area of the permanent molar. This will be recorded as a dichotomous variable (Presence/Absence) based on the European Academy of Paediatric Dentistry (EAPD) diagnostic criteria. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Autónoma de San Luis Potosí | San Luis Potosí City | San Luis Potosí | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33385533 | Background | Nogueira VKC, Mendes Soares IP, Fragelli CMB, Boldieri T, Manton DJ, Bussaneli DG, Cordeiro RCL. Structural integrity of MIH-affected teeth after treatment with fluoride varnish or resin infiltration: An 18-Month randomized clinical trial. J Dent. 2021 Feb;105:103570. doi: 10.1016/j.jdent.2020.103570. Epub 2020 Dec 29. |
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This is a split-mouth study design where each participant receives both interventions in different quadrants
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| Varnish-Modified Glass Ionomer (Clinpro XT®, 3M) | Other | Application of a site-specific, light-cured varnish-modified glass ionomer (Clinpro XT®). It provides a physical barrier and long-term fluoride release to strengthen the hypomineralized enamel. |
|
| ID | Term |
|---|---|
| D000094604 | Molar Hypomineralization |
| ID | Term |
|---|---|
| D000094603 | Dental Enamel Hypomineralization |
| D000094602 | Developmental Defects of Enamel |
| D014071 | Tooth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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